Designation:F451−08StandardSpecificationforAcrylicBoneCement1ThisstandardisissuedunderthefixeddesignationF451;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversself-curingresinsusedprimar-ilyforthefixationofinternalorthopedicprostheses.Themixturemaybeusedineitherthepredoughordoughstageinaccordancewiththemanufacturer’srecommendations.1.2Unitsofpremeasuredpowderandliquidaresuppliedinaformsuitableformixing.Themixturethensetsinplace.1.3Whileavarietyofcopolymersandcomonomersmaybeincorporated,thecompositionofthesetcementshallcontainpoly(methacrylicacidesters)asitsmainingredient.1.4Thisspecificationcoverscompositional,physicalperformance,andbiocompatibilityaswellaspackagingre-quirements.Thebiocompatibilityofacrylicbonecementasithasbeentraditionallyformulatedandusedhasbeenreportedintheliterature(1,2).21.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:3D638TestMethodforTensilePropertiesofPlasticsD695TestMethodforCompressivePropertiesofRigidPlasticsD3835TestMethodforDeterminationofPropertiesofPolymericMaterialsbyMeansofaCapillaryRheometerD1193SpecificationforReagentWaterF619PracticeforExtractionofMedicalPlasticsF748PracticeforSelectingGenericBiologicalTestMethodsforMaterialsandDevicesF749PracticeforEvaluatingMaterialExtractsbyIntracuta-neousInjectionintheRabbitF756PracticeforAssessmentofHemolyticPropertiesofMaterialsF763PracticeforShort-TermScreeningofImplantMateri-alsF813PracticeforDirectContactCellCultureE...
